吉利德Anito-cel 神经毒性低，2年多发性骨髓瘤生存率高 | ASH25

Minhua笔记12-08

在ASH 2025年会上，吉利德旗下Kite Pharma公布Anito-cel（anitocabtagene autoleucel）在iMMagine-1 II期试验中的更新数据，该靶向BCMA的CAR-T疗法在复发/难治性多发性骨髓瘤（R/R MM）患者中显示96% ORR、74% sCR/CR率、95% MRD阴性率，中位随访15.9个月，缓解持续。无延迟神经毒性（包括无帕金森样症状、无颅...

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Pharma公布Anito-cel（anitocabtagene autoleucel）在iMMagine-1 II期试验中的更新数据，该靶向BCMA的CAR-T疗法在复发/难治性多发性骨髓瘤（R/R MM）患者中显示96% ORR、74% sCR/CR率、95% MRD阴性率，中位随访15.9个月，缓解持续。无延迟神经毒性（包括无帕金森样症状、无颅神经麻痹、无格林-巴利综合征），CRS发生率83%且均为0/1级，ICANS发生率8%（1例3级，其余2级或以下），所有病例快速解决，无后遗症。12个月PFS率82.1%、18个月67.4%、24个月61.7%；12个月OS率94%、18个月88%、24个月83%，中位PFS和OS未达。Anito-cel在高风险4L+患者中展现可管理安全性和持久疗效，潜在优于Carvykti，支持其作为R/R MM新选择。III期iMMagine-3试验正在招募中，该研究将Anito-cel与标准治疗比较，预计2026年获得数据；该药物获FDA快速通道、孤儿药和RMAT资格。吉利德科学和Arcellx联合研发的靶向BCMA的CAR-T细胞疗法，可能已获得与强生Carvykti（西达基奥仑赛，ciltacabtagene autoleucel）在复发或难治性多发性骨髓瘤（RRMM）领域竞争所需的安全性优势。该疗法预计将于2026年上市。12月6日在美国血液学会 (ASH) 年会上公布的关键性 II 期 iMMagine-1 研究的最新数据显示，在接受 anitocabtagene autoleucel (anito-cel) 治疗的 117 名复发/难治性多发性骨髓瘤 (RRMM) 患者中，未出现任何迟发性神经毒性病例，包括帕金森综合征、颅神经麻痹、格林-巴利综合征或免疫效应细胞相关性肠炎。此前，一些关键意见领袖 (KOL) 表示，anito-cel 的安全性可能比 Carvykti 更具优势，其中一位专家称其未出现迟发性神经毒性“非常出色”。对于 CAR-T 治疗相关的其他副作用，包括细胞因子释放综合征 (CRS) 和免疫效应细胞相关神经毒性综合征 (ICANS)，吉利德报告了更为积极的安全性结果。ICANS 发生率为 8%，其中 1 例为 3 级；其余均为 2 级或更低。任何级别的 CRS 发生率为 86%，但吉利德指出，83% 的研究参与者要么完全没有 CRS，要么仅出现 1 级 CRS。Anito-cel 在 iMMagine-1 研究中也展现出强劲的疗效，总缓解率 (ORR) 为 96%，其中 74% 的患者达到严格意义上的完全缓解 (sCR) 或完全缓解 (CR)。尽管尚未达到中位无进展生存期 (PFS) 和总生存期 (OS)，但吉利德公布了该 CAR-T 治疗 18 个月和 24 个月的最新数据，这些数据建立在去年 ASH 会议上公布的 6 个月和 12 个月数据的基础上。12 个月、18 个月和 24 个月的 PFS 率分别为 82.1%、67.4% 和 61.7%，OS 率分别为 94%、88% 和 83%。患者对治疗的反应也很快，达到 sCR 或 CR 的中位时间为 3.2 个月。在 96 例可评估微小残留病 (MRD) 检测的患者中，95% 的患者在中位 1 个月内达到 MRD 阴性。吉利德Kite部门执行副总裁Cindy Perettie表示：“iMMagine-1所展现出的深度、持久的疗效，以及可预测、可控的安全性和快速可靠的生产，凸显了anito-cel重新定义治疗的潜力。”","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"dataReport","news_rank":0,"symbols":[],"gpt_button":1,"need_auth":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like 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